| BackguoundSanwei Traumatic Rheumatism prescription, a famous prescription of He Zhulin who is an orthopedist master from "Xi Guan Bonesetting", is composed of more than ten Chinese herbal medicines such as Panax notoginseng, Teasel root and Davallia mariesii. It has the efficacy of activating blood to remove stasis, stimulating the circulation of the blood and causing the muscles and joints to relax, reducing swelling and easing pain, expelling wind and removing dampness. It mainly treats tendon injuries, fractures, dislocations, and lumbago due to wind-wetness evil, muscle strain injuries and other diseases, being the representative of drugs for external use in the Lingnan Traumatology Department. It has been used clinically for many years in the form of a powder in the Orthopedics Hospital of Liwan District of Guangzhou City, showing an exact efficacy. In this study, based on the history finishing system of clinical uses of Sanwei Traumatic Rheumatism Prescription in the hospital, preparation process, quality standards, skin irritation and allergy test of Sanwei Traumatic Rheumatism Paste (cataplasm) was conducted. For above experiments, registration information of preparations in medical institutions has been completed, and a study of in vitro percutaneous absorption of naringin was further conducted to investigate the penetration-enhancing effect of penetration enhancers.Objective1. To study the preparation process of Sanwei traumatic rheumatoid cataplasm2. To establish the quality standards of Sanwei traumatic rheumatoid cataplasm3. To sureen the transdermal absorption enhancer of Sanwei traumatic rheumatoid cataplasm4. To inestigation the safty of Sanwei traumatic rheumatoid cataplasmMethods1.By single factor investigation, the factors that Greater impact on Cataplasm matrix include Aluminium glycinate, NP700, glycerol, EDTA. The amount of Carbomer and citric acid were fixed. The factors to consider include Aluminium glycinate, NP700, glycerol, EDTA.The L9(34) orthogonal test method was used and tacking strength, cohesive strength and apperances were used as evaluation indices.2. According to the requirement of patch described in Chinese Pharmacopoeia(Part one)(Edition 2010).We carried on the research of character, identify, check and content determination of Sanwei Traumatic Rheumatism patch.TLC was used to identify the Panax notoginseng, Teasel root, Angelica sinensis, Cortex phellodendri, Radix saposhnikoviae. HPLC was used to deterimine the content of Naringin.3. The intelligence permeation skin tester was used to investigate the different permeation enhancers on the transdermal permeation of Sanwei Traumatic Rheumatoid Paste.4. Skin irritation test and skin allergy testResults1.The optimal matrix prescription of Sanwei Traumatic Rheumatoid Paste is:carbomer:NP-700:Aluminium glycinate:glycerol:EDTA:citric acid=1.0: 10.4:0.6:70:0.02:0.1. According to the preferred process, the mid-experiment was carried out in the study, the cataplasm produced by mid-experiment was good performance, the yield was more than 95%. Which suggests that optimal conditions of the process were reasonably, practicable, and suitable for mass production.2. Results of the experiment show the identification methods that can be identifiable, reliable, specific, negative control without interference.It should contain the amount of ointent not less than 12.0 per 100cm2.Adhesion test according to adhesion assay to take on 15th ball (weight 5.64g), Adhesion test assay, cataplasm sliped to the time off should be more than 140 seconds. Shaping, weight variation, microbial limit qualification meet the requirement of Chinese Pharmacopoeia(Part one)(Edition 2010),according to the experimental results, the provisions of each piece, containine Davallia mariesii calculated by Naringin (C27H32O14) should not less than 3. Omg.3. The results show that 1% menthol is the best penetration enhancers for Naringin,24h accumulated permeation was obtained as 95.36 u g·cm-2, the permeation rate is 3.916 μg· cm-2·h-1, penetration multiples is 3.48.4. Through the skin allergic and irritation test to evaluate the security of Sanwei Traumatic Rheumatoid Paste, the experiment result shows that no obvious irritation and allergic reaction after sanwei cataplasm being applied once and several times. Sanwei Traumatic Rheumatoid Paste has no obvious side effect under the experiment.ConclusionStudy on preparation techniques in this research emphasized on close connection with actual production, as multiple batches of samples were trail-produced in medical institutions to over the limitations of disconnection between laboratory test and pilot production during studies on cataplasm; with naringin in transdermal absorption study, which is rarely seen in literature, as indicator, transdermal behaviors and effects of transdermal enhancers were explored in this product. The above studies had developed the representative recipe of "Xiguan BoneSetting", an intangible cultural heritage in Guangdong Province, into a hospital preparation convenient to use, with good compliance and accurate curative effects. This is conducive to solidify and inherit the experiences of "Xiguan BoneSetting", providing reference for the development of traditional Chinese medicine preparations for external use. |
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